FDA Registration
Active
🇺🇸 United States
POLYMEDCO, INC. / POLYMEDCO CANCER DIAGNOSTIC PRODUCTS, LLC.
Reg #: 2435505
·
FEI: 1000119795
·
Expires 2026
Products
23
Proprietary Names
29
Establishment Types
5
Classifications
23
Registration Details
- Registration Name
- POLYMEDCO, INC. / POLYMEDCO CANCER DIAGNOSTIC PRODUCTS, LLC.
- Registration Number
- 2435505
- FEI Number
- 1000119795
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 510 FURNACE DOCK RD.
- City
- CORTLANDT MANOR
- State
- NY
- ZIP
- 10567
- Country
- US
Regulatory Submissions
- 510(k) Number
- K143325
- PMA Number
- P130001
Owner / Operator
- Firm Name
- POLYMEDCO, INC.
- Operator Number
- 9001475
- Address
- 510 FURNACE DOCK RD., --
- City
- Cortlandt Manor
- State
- NY
- Postal Code
- 10567
- Country
- US
- Correspondent
- Todd - Kelley
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Reagent, Occult Blood | KHE | Class 2 | Hematology | No | 2015-08-26 |
| Test, Natriuretic Peptide | NBC | Class 2 | Clinical Chemistry | No | 2017-06-27 |
| Automated Occult Blood Analyzer | OOX | Class 2 | Hematology | No | 2009-07-09 |
| Radioassay, 17-Hydroxycorticosteroids | JHE | Class 1 | Clinical Chemistry | No | 2017-06-27 |
| Immunoassay Method, Troponin Subunit | MMI | Class 2 | Clinical Chemistry | No | 2017-06-27 |
| Calibrator, Secondary | JIT | Class 2 | Clinical Chemistry | No | 2017-06-27 |
| Antigens, All Groups, Streptococcus Spp. | GTY | Class 1 | Microbiology | No | 2009-07-09 |
| System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection | PHP | Class 3 | Unknown | No | 2017-05-10 |
| Helicobacter Pylori | LYR | Class 1 | Microbiology | No | 2009-07-09 |
| Devices Detecting Influenza A, B, And C Virus Antigens | PSZ | Class 2 | Microbiology | No | 2015-02-13 |
| Micro Pipette | JRC | Class 1 | Clinical Chemistry | No | 2017-08-11 |
| Test, Erythrocyte Sedimentation Rate | JPH | Class 1 | Hematology | No | 2009-07-10 |
| System, Test, Tumor Marker, Monitoring, Bladder | MMW | Class 2 | Immunology | No | 2008-02-01 |
| System, Test, Infectious Mononucleosis | KTN | Class 2 | Immunology | No | 2009-07-09 |
| Visual, Pregnancy Hcg, Prescription Use | JHI | Class 2 | Clinical Chemistry | No | 2009-07-09 |
| Multi-Analyte Controls, All Kinds (Assayed) | JJY | Class 1 | Clinical Chemistry | No | 2009-07-09 |
| Fibrin Split Products | GHH | Class 2 | Hematology | No | 2017-06-27 |
| Myoglobin, Antigen, Antiserum, Control | DDR | Class 2 | Immunology | No | 2017-06-27 |
| Fluorometric Method, Cpk Or Isoenzymes | JHX | Class 2 | Clinical Chemistry | No | 2017-06-27 |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | Class 1 | Clinical Chemistry | No | 2009-07-09 |
| Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | JJE | Class 1 | Clinical Chemistry | No | 2017-06-27 |
| System, Test, Tumor Marker, For Detection Of Bladder Cancer | NAH | Class 3 | Unknown | No | 2012-08-09 |
| System, Test, C-Reactive Protein | DCN | Class 2 | Immunology | No | 2017-06-27 |
Proprietary Names
OC-Light S FIT
PATHFAST NTproBNP
OC-Light iFOB Test
OC-Auto Micro 80 iFOB Test System
PATHFAST CK-MB-II
OC-Auto SENSOR io IFOB Test
PATHFAST cTnI-II
Poly stat Strep A Flip Test
Epi proColon
PolyStat H. pylori
Poly stat FLU A&B Test
Pipette Tip
PATHFAST hs-cTnI-II (High Sensitive Troponin)
Sediten ESR System
Poly stat Strep A Strip Test
BTA stat Test Kit
PolyStat Mono
PolyStat hCG
Cancer Antigen Control
PATHFAST D-Dimer
PATHFAST Myo-II
Sediplast Tubes
hCG Control
Sedimat 15 ESR System
OC-Auto SENSOR DIANA iFOB Test System
Sed-Chek 2 Controls
PATHFAST Analyzer
BTA
PATHFAST hsCRP
Establishment Types
Repack or Relabel Medical Device
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device
Manufacture Device in the United States for Export Only